Gail Warner Email & Phone Number
Director, Quality @ Edwards Lifesciences
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Gail Warner Location
- Irvine, CA, US
Gail Warner Work
- 2021 -now Director, Quality @
- 2017 -now Director, Quality @
- 2015 -2017 Senior Quality Manager, Compliance @
- 2015 -2015 Senior Manager, Quality Compliance (Senior CAPA Manager) @
- 2014 -2015 Quality Manager Complaints @
- 2013 -2014 Manager Quality Systems, Audit and CAPA @
- 2011 -2013 Post Market Surveillance and CAPA Manager @
- 2011 -2011 Stryker Spine Division RA and QA Consultant with Oxford International @
- 2009 -2010 Manager of US Product Safety and Compliance @
- 2008 -2009 Complaints Manager @
- 2008 -2008 Quality Assurance Manager @
- 2005 -2007 Quality Manager for Kerr Plant @
- 1997 -2005 Quality Systems Supervisor and Engineer @
Gail Warner Education
- Rensselaer Polytechnic Institute
BSME (Mechanical Engineering)
- University of Phoenix
MBA (Technology Management)
Gail Warner Skills
- Quality Assurance
- CAPA
- FDA
- Six Sigma
- ISO 13485
- Lean Manufacturing
- V&V
- Quality Control
- Software Documentation
- Manufacturing
- Kaizen
- Training
- Complaint Management
- Leadership
- Management
- Project Management
- Product Development
- Auditing
- Regulatory Requirements
- Testing
- 21 CFR Part 11
- Inspection
- Quality Auditing
- Cross-functional Team Leadership
- Root Cause Analysis
- Computer System Validation
- Continuous Improvement
- Design of Experiments
- Regulatory Affairs
- Design Control
- Quality Management
- GMP
- Quality System
- ISO 14971
- Sop
- Internal Audit
- Document Management
- Process Improvement
- Iso 9000
- Medical Devices
- DMAIC
- FDA GMP
- R&D
- Corrective and Preventive Action (CAPA)
- Verification and Validation (V&V)
- U.S. Food and Drug Administration (FDA)
Gail Warner Summary
- Gail Warner, based in Irvine, CA, US, is currently a Director, Quality at Edwards Lifesciences. Gail Warner brings experience from previous roles at Edwards Lifesciences, Masimo and Endologix Inc. Gail Warner holds a BSME in Mechanical Engineering @ Rensselaer Polytechnic Institute. With a robust skill set that includes Quality Assurance, CAPA, FDA, Six Sigma, ISO 13485 and more. Gail Warner has 2 emails and 3 mobile phone numbers on RocketReach.
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